The Effect of Desflurane Versus Sevoflurane Versus Propofol on Postoperative Delirium

ConditionsPostoperative Delirium Major Noncardiac Surgery Postoperative Cognitive Dysfunction

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age65+

SponsorMedical University of Vienna

About this trial

Patients over the age of 65 years are at increased risk for developing delirium after noncardiac surgeries, resulting in increased morbidity and mortality. The prevention of postoperative delirium has been classified as a public health priority. However, so far data regarding possible intraoperative interventions to reduce the incidence of postoperative delirium is very scarce. Due to the more rapid wash-in and wash-out times of desflurane as compared to sevoflurane or propofol it seems reasonable that desflurane might be beneficial for the prevention of postoperative delirium. Therefore, we evaluate the effect of maintenance of anesthesia using desflurane, sevoflurane or propofol on postoperative delirium in elderly patients undergoing moderate- to high-risk major noncardiac surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide written informed consent

≥65 years of age

Scheduled for elective major noncardiac surgery with estimated time of surgery ≥ 2 hours

Disqualifiers

Patients undergoing emergency surgery

BMI > 45 kg/m²

History of diagnosed dementia

Language, vision, or hearing impairments that may compromise cognitive assessments

Trial design

Design model

Parallel

Treatments tested in this trial

Desflurane
Drug
After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of desflurane with an intraoperative goal of bispectral index (BIS) 50±10.
Sevoflurane
Drug
After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of sevoflurane with an intraoperative goal of bispectral index (BIS) 50±10.
Propofol
Drug
After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of propofol with an intraoperative goal of bispectral index (BIS) 50±10.

Treatment groups

1,332 Participants

are divided into 3 treatment groups

Group A: Desflurane GroupExperimental treatment 1 intervention

Group B: Sevoflurane GroupActive comparator 1 intervention

Group C: Propofol GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of postoperative delirium

Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial five postoperative days while the patients remain hospitalized according to current recommendations. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium, which will be analyzed dichotomously.

Time frame

First five postoperative days

Secondary outcomes

Digit Symbol-Substitution-Test for the incidence of postoperative cognitive dysfunction (POCD)

POCD will be assessed using the Digit-Symbol-Substitution-Test (DSST). The occurrence of POCD will be defined when a patient has a Z score on two or all tests or the combined Z score is below -1.96 standard deviation (SD).

Time frame

First five postoperative days

Trail Making Test (TMT) for the incidence of postoperative cognitive dysfunction (POCD)

POCD will be assessed using the Trail Making Test (TMT). The occurrence of POCD will be defined when a patient has a Z score on two or all tests or the combined Z score is below -1.96 standard deviation (SD).

Time frame

First five postoperative days

Postoperative need of supplemental oxygen

We will record postoperative need for administration of supplemental oxygen to maintain a SpO2 of 93% during PACU or ICU stay.

Time frame

During PACU/ICU stay after surgery (max. of first 24 hours after surgery)

Length of stay in ICU

Length of stay in ICU after surgery.

Time frame

First 30 days after surgery

Other outcomes

Days at home in the first month after surgery

Number of days at home within the first 30 postoperative days.

Time frame

First 30 days after surgery

Long-term postoperative cognitive dysfunction

Long-term postoperative cognitive dysfunction will be assessed via Montreal cognitive assessment (MoCA). We will assess the baseline MoCA a day before surgery and one year after surgery via phone interview. Minimum score of the MoCA is 0 points. Maximum score of the MoCA is 22 points. Postoperative cognitive dysfunction is defined as a reduction of at least 2 points as compared to baseline.

Time frame

One year after surgery

Postoperative IL-6 concentrations (pg/ml)

Postoperative area under the curve (AUC) within the first two postoperative days of concentrations of Interleukin 6 (IL-6).

Time frame

First two postoperative days

Postoperative PCT concentrations (ng/ml)

Postoperative area under the curve (AUC) within the first two postoperative days of concentrations of Procalcitonin (PCT).

Time frame

First two postoperative days

Sponsors and contacts

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Medical University of Vienna

Lead sponsor

Medical University Innsbruck

Collaborator

Source ClinicalTrials.gov

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